Site Activation Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Act as the main point of contact and accountability for study initiation and maintenance tasks on designated projects.

• Supervise functional group project activities linked to site activation to ensure that essential path activities are accomplished promptly and within budget.

• Gather, manage, monitor, and analyze site activation tasks.

• Assist with feasibility and site identification efforts as necessary.

• Accelerate the Site Qualification and Selection process.

• Relay Site Activation & Regulatory project updates to the Sponsor, GPL/CPM, and project team.

• Create risk assessments and mitigation strategies for project deliverables.

• Ensure relevant study tasks are included in the work order budget.

• Monitor out-of-scope activities through Change Notification Forms and ensure follow-through to change order execution.

• Develop and uphold project plans related to site activation.

• Contribute to the development of SOPs, best-practice guidelines, training, and coaching.

• Provide insights for departmental process enhancement initiatives.

• Establish and analyze site activation metrics to drive corrective actions and achieve deliverables, milestones, and KPIs.

• Participate in proposals and bid defense meetings focusing on Site Activation sections, budgets, and country/study-specific activities.

• Report or escalate issues to Site Activation leadership.

• Adhere to SOPs, ICH GCP, and relevant national regulations.

• Collaborate with functional contributors and vendors.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of a four-year college degree with a focus in medical, biological, physical, health, pharmacy, or other related sciences, OR a two-year college degree or equivalent education/training (such as a nursing degree or equivalent life science degree) and experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 4 years of experience in the CRO/pharmaceutical industry, ideally in Start-up Management, Project Management, and/or Site Management.

• Proficient in cross-cultural communication.

• Proficient in both spoken and written English.

• Strong leadership and organizational management abilities.

• Capable of exercising sound judgment and making independent decisions.

• Skilled in proactively identifying and resolving issues.

• Ability to inspire, lead, and engage a team.

• Excellent interpersonal skills in a dynamic, deadline-driven, and evolving environment.

• Strong oral and written communication skills.

• Proven ability to collaborate across the organization.

• Familiarity with regulatory processes and guidelines.

• Knowledge of the initiation, planning, and execution of clinical projects and overall project management.

• Awareness of ICH GCP Guidelines and FDA/EU Clinical Trials Directives/National regulations.

• Ability to manage multiple tasks in a fast-paced and ever-changing environment.

• Capacity to work in an organized, methodical, and self-motivated manner.

• Proficient in Microsoft Word, Excel, PowerPoint, and digital systems.

• Advancement to the next level is not guaranteed based solely on years of experience; personnel are assessed based on demonstrated competency, level of responsibility, and ability to work autonomously.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible leadership.

• Equal employment opportunities.

• Training and coaching opportunities related to the Site Activation department.